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Instrument/analyser IVDs - ARTG 475209

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 475209 and sponsored by Abacus dx Pty Ltd, manufactured by Inpeco SA in Switzerland. The device registration started on January 08, 2025.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class I
ARTG 475209
Class I
Instrument/analyser IVDs
ARTG ID: 475209
Good Name: Abacus dx Pty Ltd - Instrument/analyser IVDs
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Intended Purpose

ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
475209
Start Date
January 08, 2025
Effective Date
January 08, 2025
Manufacturer
Country
Switzerland
Address
Via Torraccia 26, Novazzano, CH-6883